They did do a 12 month check-in which is good, but why such a small group of study participants, especially when malaria is so widespread?
[1] https://clinicaltrials.gov/study/NCT04300309?term=CALINA&ran...
We also already have data about its use in babies over 11 lbs, and this is just going even smaller to 4.4 lbs, so a strong baseline has already been demonstrated.
The scientific method, though, would dictate that a cohort size should be large enough to show a high probability of safety and efficacy, assuming that is what is being tested. It would also dictate that a control group would be needed to compare against the test group.
I totally understand the ethical concerns of potentially allowing children to be harmed while part of a control group, but when the test is being done specifically because there is currently no treatment the only change is that they would pick a group of untreated children that are a valid control group for the study. Either way those children wouldn't be treated and there really isn't an ethical issue to deal with.
> Until now there have been no approved malaria drugs specifically for babies.
> Instead they have been treated with versions formulated for older children which presents a risk of overdose.
I assume you're well-aware the process for something like this doesn't fit in a sentence.
Additionally, there's context in the comment you're replying to, this isn't the only study.
I'm particularly confused by that last one. How is malaria considered an adverse event when testing an anti-malaria treatment? Other data in the study shows that 1 participant had malaria again with matching DNA, meaning the original infection likely came back. 6 others were reported as getting malaria again but with different DNA. So what does it mean to have 9 with the adverse event of malaria?
I'm sure you mean well -- since your post, the thread got cluttered up with outright know-nothing-type comments. I am being very literal in order to help teach people in despair what we expect when we read these.
My uncertainty is that I may be misunderstanding the meaning of malaria as an adverse event entirely here - I don't get how reinfection would be an adverse event rather than a potential failure of treatment.
The study is only useful if it can show safety and efficacy of the dosage levels for the test population. I'm not trying to argue that the study was even necessary if the safety and efficacy can be implied, only that if the study is to be done it should at least be setup with a chance of proving the needed results.
Edit: it's a very welcome addition. Limits side effects.
Because they use a plant to prevent and heal it. I can't recall the name of this plant but I remember I saw a documentary stating that China tried multiple times to export that plant to the world but Bill Gates, who is interested in the subject and wanted to develop a vaccine for malaria, for a long time convinced the world health organization to not allow that on the name that the plant has health risks, inefficient and is dangerous to the environment.
The drug the article is talking about contains artemisinin in combination with another substance.
We know how to deal with malaria, so this isn't some story of Big Pharma hiding the truth. The disease used to be endemic in the US and in Europe. Better treatments save lives, but eradication hinges on economic and political factors... which are in turn not helped by malaria.
Malaria is still a public health concern in Africa. And that's where Bill Gates does not want to see that plant exported to Africa because, unlike the Big Pharma products, it is a cheap solution.
I do not think we are talking about the same plant because "sweet wormwood" exists in Africa (a variant of it). Unfortunately I can't find the documentary I saw some years ago about this. It was done by few French investigation journalists.
Trade is subject to lobbyism (to say the least)
Now that the white wormwood based treatment is known worldwide, there are questions about whether it should be kept in reserve like quinine. I'm not sure if things have changed, but I recall an approach is to give Artemisinin alongside another treatment, to prevent malaria from adapting. In africa, people will commonly listen to the doctor's instruction to take the whole course of medicine and will ignore it and just take half. They give the other half to a relative. This causes treatment resistant malaria to develop.
I would think that any reasonably intelligent adult could think about things for a few moments and come to the realization that... yeah, that's how things work. This is how we progress and learn. We develop, test, use, and learn about things - and if we learn that hey, turns out, this is bad over a long period of time... we change things.
And this of course doesn't apply to just medicine - it's just technological progress.
Most indignities are lesser than dying of malaria.
It gets pretty bad though when others are affected, cf. Thalidomide babies.